Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302426
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-01-16
Brief Title:
Trial of INI-4001 in Patients With Advanced Solid Tumours
Sponsor:
Inimmune Corporation
Organization:
Inimmune Corporation
Study Overview
Official Title:
An Open-label Multiple-Ascending Dose Two-Part Dose Ranging and Cohort Expansion Study of INI-4001 in Patients With Advanced Solid Tumours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1 open-label dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors
Detailed Description:
This is a Phase IaIb open-label dose-escalation and dose expansion study This study will be conducted in two parts Phase Ia dose escalation and Phase Ib dose expansion Phase Ia will initially seek to establish the MTD of INI-4001 administered as a monotherapy Following identification of the MTD any dose level at or below the MTD may be further expanded to further explore the safety PK PD and preliminary efficacy of INI-4001 alone and in combination with a complementary therapy Phase Ib
Following cessation of INI-4001 patients will be requested to participate in long-term follow-up to assess overall survival This long-term follow-up will continue for each patient until at least 1 year after their last dose of INI-4001 or until otherwise advised by the Sponsor
Following cessation of INI-4001 patients will be requested to participate in long-term follow-up to assess overall survival This long-term follow-up will continue for each patient until at least 1 year after their last dose of INI-4001 or until otherwise advised by the Sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None